Impact of Breather Device on Ventilatory Effort in Patient With MTMD

NCT06562556 | Not Yet Recruiting

• 1 other identifier: breather device for MTMD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

PURPOSE: The purpose of the study is to investigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders To investigate the effect of the breather device on craniocervical angle and oral Health quality in patients with myogenic temporomandibular joint disorders BACKGROUND: TMDs affect between 5% and 12% of the population which is presented by symptoms such as pain in the masticatory muscles with a decrease in the mandible's movement. Other symptoms include ear pain, headache, joint sounds with mandible movement, and/or functional limitations in the jaw like swallowing difficulties commonly found. (Hatice ., et al 2023) Increased prevalence of TMDs has been linked to physical, psychological, and hormonal changes throughout pubertal development. The age predisposes to the development of masticatory system problems in students since symptoms peak between the ages of 20 and 40 years. Women of breeding age are the majority of TMD sufferers. The prevalence of TMD increases globally throughout adolescence and may vary from 7% to 30% of the population (Loster ., et al2017). Alterations of body posture, upper thoracic breathing pattern, and mouth breathing constitute causal factors for the overuse of the accessory inspiratory musculature, which generates hyperactivity and consequently, alteration of head position, and mandibular traction. (Kim., et al 2017) HYPOTHESES: There will be no significant effect of the breather device on ventilatory effort in patients with myogenic temporomandibular joint disorders. There will be no significant effect of the breather device on a craniocervical angle and oral Health quality in patients with myogenic temporomandibular joint disorders RESEARCH QUESTION: Does the breather device can improve ventilatory effort in patients with myogenic temporomandibular joint disorders?.

Conditions

TMD

Outcome Measures

Primary Outcomes (2)

• spirometer

  measure ventilatory function test in percentage 1. Forced expiratory volume in the first second (FEV1) 2. Forced vital capacity (FVC). 3. FEV1/FVC ratio. 4. Maximal Ventilator Volume (MVV)

  4 weeks

• Surface electromyography (sEMG):

  To evaluate nerve-muscle activity during static conditions and active movements of the scalene muscle and sternocleidomastoid muscle

  4 weeks

Secondary Outcomes (5)

• Fonseca Anamnestic Index (FAI)

  4 weeks

• Numeric Pain Rating Scale (NPRS)

  4 weeks

• craniocervical angle measuring

  4 weeks

• The Oral Health Impact Profile Questionnaire OHIP-14

  4 weeks

• Tape Measurement tool and height scale

  preassessment

Study Arms (2)

Participant Group/Arm

EXPERIMENTAL

rThirty patients, will receive a combined treatment program containing respiratory muscle training by the breather device with a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week)

Device: the breather device; Other: conventional exercise program

Control group/Arm

OTHER

Thirty patients, who will receive a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week).

Other: conventional exercise program

Interventions

the breather device DEVICE

investigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders

Participant Group/Arm

conventional exercise program OTHER

-Therapeutic Ultrasound (US): Ultrasound therapy will be applied at the site of pain over the TMJ area with Frequency: 1 MHz, Mode: continuous, Duration: 6 min. each session 2-Myofascial release for masticatory muscles 3-The self-exercise Self exercise: include simplified myo-functional therapy. 10 repetitions, three: five times per day 4-Techniques to correct deglutition: swallowing a small amount of water and speaking while holding a semi-hard small object between the dental arches 5-Relaxation exercise of Masticator Muscle:10 repetitions, three. 6-Strain-counterstain (SCS): applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck muscles

Control group/Arm; Participant Group/Arm

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: sixty women patients with chronic pain myogenous TMD for more than three months will be included in our study., their ages will range from 20 to 40 years. They will be selected from students of Misr University for Science and Technology to be enrolled in this study. They will participate in this study for 4 weeks.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sixty female patients who fulfilled the RDC/TMD criteria of myofascial pain and the presence of parafunctional habits, such as bruxism, teeth grinding, mouth breathing, and lip biting.
• The Patient's ages will range from 20 to 40 years.
• Patients with a waist-height ratio measuring less than 0.5. 5- Patients with a craniocervical angle measuring from 30 to 50° (Bo-Been et al., 2016).
• the patients have points from 20-65 on the Fonseca Anamnestic Index (FAI) 7- the patients have the willingness to participate in this study. 8- All patients will sign a consent form before starting the study.

You may not qualify if:

• Patients will meet one of the following criteria will be excluded from the study:
• patients undergo surgery or trauma in the orofacial region; systemic or degenerative odontologic disease.
• The patient has Surgery or trauma in the spine and upper limb.
• Patients suffering from rheumatic diseases and other severe comorbidities.
• Patients suffering from any respiratory diseases (restrictive, obstructive, suppurative diseases).
• Patients suffering from neurological disorders affecting respiratory muscles or any muscular dystrophies

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• Walczynska-Dragon K, Baron S, Nitecka-Buchta A, Tkacz E. Correlation between TMD and cervical spine pain and mobility: is the whole body balance TMJ related? Biomed Res Int. 2014;2014:582414. doi: 10.1155/2014/582414. Epub 2014 Jun 19.

  PMID: 25050363 RESULT

Central Study Contacts

weaam Hasaneen, assistant lecturer

CONTACT

010111421509; weaam.hosain@must.edu.eg

Hany Ezzat, Assistant professor

CONTACT

01001746517; Hany_obaya@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asssisstant lectruer

Model Details: Group A: (Experimental group) Thirty patients, will receive a combined treatment program containing respiratory muscle training by the breather device with a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week). Group B: (Control group) Thirty patients, who will receive a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week)

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08